Section-I - rku.ac.inrku.ac.in/syllabus/syllabus/SOP-Bpharm-Sem-5-Bpharm-2018-2019-SOP-RKU.p…3 Immunology and Immunological Preparation: Immunity, primary and secondary defense mechanism,

Course Title PHARMACEUTICAL BIOTECHNOLOGY

Course Code PH501

Course Credit

Lecture : 3

Practical : 2

Tutorial : 0

Total : 5

Course Objectives

On the completion of the course, students will be able to:

To understand the basics concepts of biotechnology and to elaborate scope of

biotechnology based products as compared to chemically derived products.

To learn various strategies involved in microbial biotechnology industries.

To provide knowledge regarding production of antibiotic, organic acid, vitamins, amino

acid and industrial alcohol.

Detailed Syllabus

Sr. No.

Name of Chapter & Details Hours Allotted

Section-I

1 Introduction to biotechnology 02

2 Genetic recombination:

Transformation conjugation, protoplast fusion, gene cloning and their

applications, monoclonal antibodies. Study of drug produced by

biotechnology, viz. activase, humulin etc.

08

3 Immunology and Immunological Preparation:

Immunity, primary and secondary defense mechanism, interferon,

principles of immunology, antigen antibody reactions and application,

preparations of vaccines, toxoids, standardization and storage.

07

4 Blood Products and Plasma Substitutes: Collection, processing and

storage of whole human blood, concentrated human RBCs, dried human

plasma, formulation and storage consideration for blood products.

04

5 Surgical Products: List of surgical products, surgical instrumentation and

accessory, introduction of surgical products.

02

Section-II

6 Microbial Transformation :

Introduction, types of reactions mediated by microorganisms, design of

biotransformation processes, selection of organisms, biotransformation

process and its improvements with special reference to steroids.

06

7 Immobilization of Enzymes:

Techniques of immoblilization, factors affecting enzyme kinetics, study

of enzymes such as hyaluronidase, penicillinase, streptokinase,

streptodornase, amylases and proteases etc., Immobilization of bacteria,

06

applications.

8 Fermentation Techniques:

Screening of organism, preparation and preservation of master culture,

design of fermentor, various parameters and media used for

fermentation, recovery of fermentation products flowsheets penicillin,

streptomycin, vit. B2, vit. B12.

10

Pharmaceutical Biotechnology-I (Practical)

1. Microbiological assay of antibiotics.

2. Preparation of vaccines.

3. Standardization of vaccines.

4. Preparation of mutant by Gradient plate method.

5. Preparations of mutant by Velvet replicate method.

6. Design of fermentor and demonstration of fermentation process and instrument.

7. Study of shake flask technique.

8. Production of alcohol using Bakers yeast.

9. Extraction of citric acid from fermented mass.

10. Studies of effect of environmental factors on growth of microorganism.

11. Other practicals covering syllabus aspects.

Instructional Method and Pedagogy:

Lectures will be conducted with the aid of multi-media projector, black board, OHP etc.

Assignments based on course content will be given to the students at the end of each

unit/topic and will be evaluated at regular interval.

Surprise tests/Quizzes/Seminar/Tutorials will be conducted .

The course includes a laboratory, where students have an opportunity to build an

appreciation for the concepts being taught in lectures.

Students Learning Outcomes:

Know the concepts of biotechnology.

Understand in detail the structure, functions and characteristics of enzymes and enzyme

kinetics.

Apply knowledge in various strategies involved in biotechnology industries.

Know behaviour of immune system and molecules involved therein towards development

of diagnostic methods and vaccines.

Text Books:

1. Foundations in Microbiology by Patil Ulhas.

2. Hugo & Russell's Pharmaceutical Microbiology by Denyar S.P ,Editor.

3. Pharmaceutical Microbiology : Experiments and Techniques by Kokare Chandrakant R.

4. A Text Book of Pharmaceutical Microbiology by Shah. Dushyant and Shah Yamini.

5. Pharmaceutical Microbilogy by Kar Ashutosh.

6. Microbiology Fundamentals and Application by Purohit S.S .

Reference Books:

1. Textbook of Microbiology by Tortora.

2. Bergeys manual of Systematic Bacteriology, Williams and Wilkins- A Waverly

company.

3. Microbiology, Pelczar/Chan Kreig Tata McGraw Hill edn.

4. Industrial microbiology. Fourth edn, Prescott and Dunn. CBS publishers and distributors.

5. Principles of fermentation tehchnology. Second edn. P. F. Stanbury, A. Whiteshaker and

S. J. Hall Aditya Books Pvt Ltd. New Delhi.

Additional Resources

Soft copies pharmaceutical biotechnology books are available on

http://www.pharmatext.org

Latest information regarding pharmaceutical biotechnology are available on

http://www.pharmainfo.net and in mypharmaguide.com.

Course Title Drug regulatory affairs

Course Code PH502

Course Credit

Lecture : 2

Practical : 0

Tutorial : 0

Total : 2

Course Objectives

This subject gives basic knowledge about Intellectual Property Rights, Various Concepts of

copyrights, trademarks and geographical limitations.

This subject gives details about guidelines and procedures for application of investigational

drug, new drug and abbreviated new drug in various countries.

Detailed Syllabus

Sr. No.

Name of Chapter & Details Hours

Allotted

SECTION I

1 Drugs and Cosmetics Act 1940 and Rules 1945

Indian Drug Regulatory Process- Role of FDA, DCGI in Indian drug regulation 06

2 Good Manufacturing Practice for Pharmaceuticals:

Brief Introduction to GMP (Schedule M), standard operating procedure (SOPs),

Building, Equipment, Personnel, Components, Documentation, Containers,

03

Labeling, Laboratory Control, Distribution Records, Recovery & Reprocessing.

3 Narcotic Drugs & Psychotropic Substances Act 1985 & Rules: 03

4 Drug Price Control Act 01

5 Prescription – Non Prescription Product 01

6 Drug Policy (latest) 01

SECTION II

7 IND: submission, format & content of IND, content of Investigator. 02

8 Brochure, general consideration of New Drug Approval (NDA), specific

requirements, content & format of NDA, manufacturing control requirement of

NDA.

04

9 ANDA: Concept of para I to IV, exclusivity: Content, format, development flow

sheet and Application.

04

10 Brief and comparative introduction to various regulatory agencies and standard

institutions (Historical perspectives, activities & responsibilities): US-FDA, TGA,

MHRA, WHO, ICH, ANVISA, MCC, EMEA, CANADA etc.

05





Surprise tests/Quizzes/Tutorials will be conducted.


At the end of the course the students will be able to:

Know about Intellectual Property Rights, various concepts of copyrights, trade mark and

geographical limitations.

Know details about guidelines and procedures for application of investigational drug, new

drug and abbreviated new drug in various countries.

Text books:

1. P. P .Sharma “How to practice GMPs”, 3rd edition, Vandana Publication

2. CGMP :Current Good Manufacturing Practices For Pharmaceuticals By Potdar Manohar A.,

CBS Publishers

3. Review article published in international journal relevant to topic.

Reference Books:

1. New drug approval process: Accelerating Global registrations By Richard A Guarino, MD,

5thedition , Drugs and the pharmaceutical sciences, Vol. 190.

2. Guidebook for drug regulatory submissions/ Sandy Weinberg By John Wiley & Sons. INC.

3. FDA regulatory affairs: A guide for prescription drugs, , medical devices, and biologics/edited

by Douglas J. Pisano, David Mantus.

4. Drugs from discovery to approval, Second edn, by Rick N. G.

5. New drug development: A regulatory overview, 8th edn, by Mark Mathieu

6. Preparation and maintenance of the IND application in eCTD Format by William K. Sietsema

7. Medical product regulatory affairs: Pharmaceuticals, Diagnostics, medical devices by John J.

Tobin and gary Walsh.

8. Drugs and Cosmetics Laws by Krishnan Arora, Professional Book Publishers, New Delhi

9. Drugs and Cosmetics Laws by Krishnan Arora, Professional Book Publishers, New Delhi.

10. Gnarino Richard A, New Drug Approval Process, 3rd Ed., Marcel Dekker Inc.

11. P. Warayan, Intellectual Property Laws, Eastern Law House.

12. Ira R. Bery, “Introduction to the Pharmaceutical Regulatory Process”, Drugs and Pharm Sci.

Series, Vol. 144, Marcel Dekker Inc., N.Y.

13. Indian Pharmacopoeia, Vol. 1-3, 2007.The Indian Pharmacopoeia commission, Ghaziabad,

Govt. of India.

14. The International Pharmacopoeia Vol 1,2,3,4,5 3rd Edition

15. “WHO Expert Committee on specification on Pharmaceutical Preparation”34th report,

Geneva, World Health Organisation, 1996 (WHO Technical Report Series, No. 863.

16. A. C. Cartwright and Brian Mathews, “International Pharmaceutical Registration” Taylor and

Francis Ltd. UK, 2002.

17. P. Warayan, Intellectual Property Laws, Eastern Law House.

18. Drug and Cosmetic Act 1940, Eastern Book company by Vijay Malic, 11th Ed. Patents for

Medicine, by N. B. Zareri, Indian Drug Manufacturers Association (IDMA)


Soft copies of drug regulatory affairs and intelectual property right books are available on

http://www.pharmatext.org, www.pharmacyebooks.com, and in www.pharmamirror.com.

Latest information regarding drug regulatory affairs and intelectual property right are

available on http://www.pharmainfo.net

Study material of drug regulatory affairs and intelectual property right are available on

mypharmaguide.com, pharmatutor.com, authorstream.com, slideworld.com and in

scribd.com.

Course Title MEDICINAL CHEMISTRY- I

Course Code PH503

Course Credit

Lecture : 3

Practical : 3

Tutorial : 0

Total : 6

Course Objectives

Medicinal chemistry-I will provide the sound knowledge about basic principles of medicinal

chemistry like development of various drugs on various basis, Nature and Property of various

class of drugs, influence of these property on biological activity/potency, basic about

receptors, their sites and interaction of same with different drugs, to study stereo-chemical

aspect of drugs, study of importance, property, synthesis of various Heterocyclic chemicals,

and detail study about the drugs and their effect on autonomic system, and atocoids

Detailed Syllabus - Theory

Sr. No.


Section-I

1 An introduction to the subject of medicinal chemistry

History and development of branch medicinal chemistry. Application of

medicinal chemistry in pharmacy.

02

2 Physiochemical properties of drug molecules influencing biological activity

A. Solubility, Partition coefficient, Hydrogen bonding, Complexation,

Ionization, Redox potential, Surface activity and protein binding

B. Stereochemical features of drugs: Geometric and Optical isomers, Bio-

isosterism

06

3 Receptors and Drug action:

A. Types of receptors

B. Theory of receptors

C. Drug-receptor interaction and factors affecting it

03

4 Heterocyclic compounds:

Chemistry, preparation and properties of:

A. Five membered heterocyclic rings having one hetero-atom:

Furan, Thiophene and Pyrole

B. Five membered heterocyclic rings having two hetero-atoms:

Pyrrazole, Imidazole, Oxazole, Isoxazole and Thiazole

C. Six membered heterocyclic rings having one/two hetero-atoms:

Pyridine, Pyrimidine

D. Fused heterocyclic rings:

Quinoline, Isoquinoline and Indole

12

Section-II

5 Introduction, history, classification, nomenclature, mechanism of action,

adverse effects, therapeutic uses, structure activity relationship (SAR) and

synthetic procedures of selected drugs and recent developments of

following categories to be covered.

Drugs acting on ANS

A. Cholinergics:

12

SAR- Acetylcholine mimetics- Muscarinic agonists

B. Anticholinergics:

SAR:- Acetylcholine Antagonists- Muscarinic antagonists

Synthesis of Neostigmine, Dcyclomine hydrochloride

C. Adrenergics:

SAR:- Phenylethanolamines

Synthesis of Adrenaline, Dopamine, Isoprenaline, Ephedrine

D. Adrenergic antagonists:

Synthesis of Naphazoline, Salbutamol

E. Neuromuscular blocking agents and ganglionic blockers:

I. Ganglion blocking agents: trimethaphan, camsylate, mecamylamine

II. Neuromuscular blocking agents: tubocurarine, gallamine,

triethiodide, succinyl choline chloride

6 Autocoids

A. Histamines and anti-histamines:

Histamine receptors, H1 antagonists, H2 antagonists (histamines,

diphenhydramine, tripelenamine, chlorcylclizine, trimeprazine,

chlorpheniramine, promethazine, cyproheptadiene, antazoline,

cetrizine)

B. Eicosanoids:

History and discovery, eicosanoids biosynthesis, drug action

mediated by eicosanoids, eicosanoids approved for human clinical

use.

10

Medicinal Chemistry-I (Practical)

To Study about the Common hazards that are probable to occur in medicinal chemistry

laboratory.

Laboratory First aid and treatments procedure for various kinds of injuries.

Common laboratory techniques used in organic chemistry laboratory.

To study principles and reactions for identification of organic compounds

Systematic identification of organic compounds

1. To study about separation principles of various kinds of solid-solid and eutectic mixtures

satisfying above all criteria.

2. To carryout identification, separation and spotting of given unknown binary organic

mixture (solid-solid binary organic mixture and eutectic mixture)

3. To use TLC for matching Rf value of different components of mixture for identification

purpose


1. Know the basic concepts of medicinal chemistry, its scope and various branches.

2. Know the mechanism of action and effects of drugs on various organs of the body.

3. To study about chemistry of individual drug molecule.

4. To study about drug interactions and adverse effects.

5. To study in detail about the SAR (structure activity relationship) of different classes of

drugs.

6. Know about the development of new drug.

7. To study separation techniques (physical and chemical) of mixture component and

identification methods of the same.

Text Books:

1. Foe’s principles of medicinal chemistry. David A. Williams & Thomas L. Lemke. Lippincott

Williams & Wilkins.

2. Wilson and Griswold’s textbook of organic medicinal and Pharmaceutical Chemistry,

John H. Block and John M. Beale, Jr.. Lippincott Williams & Wilkins.

Reference Books:

1. Harkishan Singh and V.K Kapoor – text book of medicinal chemistry.

2. Medicinal chemistry by ashutoshkar

3. Principles of medicinal chemistry by kadam and bothara

4. Experimental organic and medicinal chemistry by biren n., shah. S. vikas.

5. Practical organic chemistry, Hitesh G. Raval, Sunil L. Baldania, Dimal A. Shah, Nirav and

Roopal Prakashan.

6. Burger’s Medicinal Chemistry and Drug Discovery, Donald j Abraham, Wiley interscience.

7. Vogel’s text book of practical organic chemistry.

8. Practical organic chemistry by F.G Mann and Saundars


Soft copies of important topics to be covered.

Collect and share latest informations available from scientific journals available on e-library

and on websites.

Seminars and oral presentation on some specific topic.

Course Title BIOCHEMISTRY

Course Code PH504

Course Credit

Lecture : 3

Practical : 2

Tutorial : 0

Total : 5

Course Objectives

Biochemistry will help to know the concept of different type of constituent of our biochemical

system and enlighten them to biochemical reaction, roles of enzymes in our body and the

genetic makeup of our body. They will able to identify different type of food stuffs and their

roles in our body. They also aware about the different minerals and their utility in our body. It

also make them aware of quantitative determination of various biological products by different

techniques.

Detailed Syllabus - Theory

Sr. No.


Section-I

1 Introduction to Carbohydrates, Proteins and Lipids. Biochemical

Organization of the cell and Transport Processes Across cell

Membrane.

7

2 The Concept of free energy, Determination of Change in free energy from

Equilibrium Constant and Reduction Potential, Bioenergetics, Production of

ATP and its Biological Significance

3

3 Enzymes:

Nomenclature, Enzyme Kinetics and its Mechanism of action, Mechanism of

Inhibition, Enzymes and Iso-Enzymes in Clinical Diagnosis

Co-Enzymes:

Vitamins as Co-Enzymes and their Significance. Metals as Co-Enzymes and

their Significance.

5

4 a. Carbohydrate Metabolism:

Conversion of Polysaccharides to Glucose-1-Phosphate. Glycolysis and

Fermentation and their Regulation, Gluconeogenesis, Glycogenesis and

Glycogenolysis

b. The Citric Acid Cycle:

Significance, Reaction and Energetic of the Cycle, Amphibolic Role of the

Cycle and Glyoxalic Acid Cycle, Uric Acid Cycle

6

5 Techniques used in biochemistry: spectrophotometry, centrifugation,

electrophoresis, chromatography, extraction and purification of nucleic

acids

2

Section-II

6. Lipid metabolism: oxidation of fatty acids, beta-oxidation and energetic,

alpha-oxidation, omega-oxidations, biosynthesis of ketone bodies and their

utilization, biosynthesis of saturated and unsaturated fatty acids, control of

lipid metabolism and metabolism of cholesterol

6

7. Biological oxidation, enzymes and co-enzymes involved in oxidation 4

reduction and its control. The respiratory chain, its role in energy capture

and its control, energetic of oxidative phosphorylation, inhibitors of

respiratory chain and oxidative phosphorylation, mechanism of oxidative

phosphorylation

8. Metabolism of ammonia and nitrogen containing monomers: biosynthesis

of amino acids, catabolism of amino acids, conversion of amino acids to

specialized products. Assimilation of ammonia, urea cycle. Metabolic

disorders of urea cycle, metabolism of sulphur containing amino acids,

porphyrin biosynthesis, formation of bile pigments, hyperbilirubinemia,

purine biosynthesis, purine nucleotide interconversion, pyridine

biosynthesis

6

9 Biosynthesis of nucleic acids. Brief introduction of genetic organization of

the mammalian genome, alteration and rearrangement of genetic material,

biosynthesis of DNA and its replication, DNA repair mechanism,

biosynthesis of RNA

Genetic code and protein synthesis: genetic code, components of protein

synthesis and inhibition of protein synthesis. Brief account of genetic

engineering and polymerase chain reactions

6

Biochemistry (Practical)

1. Analysis of Normal and Abnormal Constituents of Urine.

2. Estimation of Chlorides, Phosphates, Acidity and Ammonia, Glucose in Urine,

Gastric Juice.

3. Identification of Carbohydrates and Proteins.

4. Biochemistry of Cheese, Milk, Bread and Bile.

5. Identification of Substances of Physiological Importance.

6. Achromic and Chromic Period of Salivary Amylase.

7. Analysis of lipids.

8. Biochemistry of gastric juice.

9. Biochemistry of flour and potato.

10. Estimation of calcium in serum.

11. Estimation of calcium and magnesium in urine.

12. Colorimetric analysis of

i. Glucose, creatinine and urea in blood

ii. Protein, bilirubin and cholesterol in plasma





Surprise tests/Quizzes/Seminar/Tutorials will be conducted.

The course includes language practices such as Group Discussion, Interviews etc to develop

the communication skills of the students.


8. Know the basic concepts of biochemistry, its scope and various branches.

9. Know the mechanism biochemical reaction and effects of on various organs of the body.

10. Know various techniques of quantitative and qualitative method to identify the

biochemical product.

Text Books:

1. U. Satyanarayan, Biochemistry, Books and allied (P) ltd. Calcutta, latest edn.

2. A. C. Deb, Fundamental of Biochemistry, 7th edition.

Reference Books:

1. E. E. Conn and P. K. Stumpf, Outlines of biochemistry, John Wiley and Sons, NewYork.

2. A. L. Lehninger, Principles of biochemistry, CBS Publishers and Distributors.

3. R. K. Murray, D. K. Granner, P. A. Mayes. V.W. Rodwell, Harpers Biochemistry, Prentice hall

International Inc. latest edn.

4. S. C. Rastogi, Biochemistry, Tata McGraw Hill New delhi, Latest edn.

5. M.Cohn, K.S. Roth, Biochemistry and Disease. William and Wilkins co. Baltimore,Latest edn.

6. G. F. Zubay, W. W. Parson, D. E. Vance, Principles of Biochemistry, WCB Publishers, England,

latest edn.

7. S. Ramkrishnan, K. G. Prasannan, R. Rajan. Textbook of medical Biochemistry, Orient

Longman Madras, Latest edn.

8. S.K. Sawhney, Randir Singh Eds, Introductory practical Biochemistry, Narosa Publishing

house New Delhi.

9. D. T. Plummer, An Introduction to Practical Biochemistry, Tata McGraw Hill NewDelhi.

10. J. Jayaraman, Laboratory manual in Biochemistry, Wiley eastern Ltd. New Delhi.

Course Title PHARMACOLOGY- II

Course Code PH505

Course Credit

Lecture : 3

Practical : 3

Total : 6

Course Objectives

Pharmacology II will give detailed knowledge about the pharmacokinetics,

pharmacodynamics, receptor mechanisms, drug interactions, contraindications and

adverse drug reactions of various drugs used for CNS disorders like parkinsonism, epilepsy,

pain, migraine, psychoses, insomnia, anesthesia, CNS stimulation, sedation, etc. It will also

provide thorough information about pharmacology of drugs used in gout and rheumatoid

arthritis, drugs used for gastrointestinal and respiratory and endocrinal disorders and of

immunomodulators.

Detailed Syllabus

Sr. No.


Section-I

1 Drugs acting on Central Nervous system:

a. Neuronal transmitters in CNS

b. General Anesthetics

c. Ethyl and Methyl Alcohols

19

d. Sedatives and Hypnotics

e. Anxiolytic Agents and antidepressants

f. Centrally acting Muscle Relaxants

g. Antipsychotics

h. Antimaniacs

i. Antiepileptic Drugs

j. Antiparkinsonian Drugs

k. Opioids Analgesics and Antagonists

l. CNS Stimulants, Respiratory stimulants and Psychotomimetic

Agents

m. Drug Dependence and Drug abuse

2 Non-steroidal anti-inflammatory drugs and drugs used in management

of gout and rheumatoid arthritis

4

Section-II

3 Pharmacology of Endocrine system

a. Hypothalamic & pituitary hormones

b. Thyroid and antithyroid drugs, parathormone, calcitonin and

vitamin D and other agents that affect bone mineral homeostasis

c. Glucagon, insulin, Antidiabetic drugs and oral hypoglycaemic

drugs

d. Corticosteroids

e. Gonadal Hormones and inhibitors

f. Oxytocics and Tocolytics

15

4 Pharmacology of drugs acting on Respiratory system

a. Drugs used in bronchial asthma

b. Drugs used in cough

03

5 Drug Acting on the Gastrointestinal Tract

a. Anti-ulcer drugs (Antacids, Anti-secretory agents etc.) and Gastro-

Esophageal Reflux Disease (GERD)

b. Drugs used as Emetics and Anti-emetics

03

6 Immunomodulators 02

Pharmacology-II Practical

Experiments:

1. Study of Analgesic and Anti-Inflammatory Activity of drugs

2. Study of the Effects of CNS Stimulant (Coffee/Tea) on Human Volunteers.

3. Study of effects of CNS Stimulants and Depressants on spontaneous motor activity in

mice using Actophotometer

4. Study of the effect of Skeletal Muscle relaxants in mice using Rota Rod apparatus.

5. To study the effect of drugs on behavioral changes in rat/mice (stereotypic behavior,

catatonia, anxiety by plus maze apparatus)

6. To study the effect of anticonvulsant drugs in mice

7. To study the effect of drugs on histamine induced bronchospasm

8. To study the effect of antiulcer drugs using rats

9. To find out the nature of Unknown Drugs (Acetylcholine, Histamine, Bacl2,

Physostigmine, Atropine, Mepyramine and Papaverine) using Rat/Guinea Pig Ileum

Preparation.

Demonstration experiments

1. To demonstrate the effect of anti-motility drugs using mice/rat

2. To demonstrate bioassay of oxytocin using rat uterus

3. To demonstrate effect of l-thyronine on respiration rate

4. To demonstrate the effect of hypoglycemic agents on blood sugar level (metformin,

glibenclamide/Insulin) using experimental animals.






The course includes language practices such as Group Discussion, Interviews etc to

develop the communication skills of the students.


11. Know the details of pharmacology of drugs used in various CNS, respiratory,

gastrointestinal, endocrinal disorders and of immunomodulators.

12. Know various alternatives available for a single disease which can be because of

multiple pathophysiologies.

13. To study the detailed pharmacokinetics and pharmacodynamics including drug

interactions, precautions, contraindications and adverse drug reactions of all the

category of drugs.

Text Books:

3. Essentials of medical pharmacology --K. D. Tripathi

4. Pharmacology-Rang and Dale

5. Harvel, R.A., Champe P.C. et al – Pharmacology. Lippincott-Raven Company,

Philadelphia, New York.

6. Satoskar R.S. et al – Pharmacolog and Pharmacotherapeutics. Popular Prakashan,

Mumbai.

7. Handbook of Experimental Pharmacology- Goyal R.K.

8. Handbook of Experimental Pharmacology- Kulkarni S.K.

Reference Books:

9. Pharmacological basis of Therapeutics-Goodman and Gilman

10. Seth S.D. Text book of Pharmacology, B. I. Churchill, 1997.

11. Principles of Pharmacology – Paul L. Munson

12. Modern Pharmacology with clinical applications- Craig, Charles R.

13. Principles of pharmacology.--H. L. Sharma

14. Pharmacology and Toxicology- Kale S.R.

15. Ghosh M.N. Essentials of Experimental Pharmacology. Scientific book Agency,

Calcutta.


Soft copies of pharmacology and pathophysiology books are available on websites.

Latest informations are available from scientific journals available in library and on

websites.

Course Title PHARMACEUTICAL TECHNOLOGY I

Course Code PH506

Course Credit

Lecture : 3

Practical : 3

Tutorial : 0

Total : 6

Course Objectives

On the completion of the course, students will be able to:

Understand the basic concepts of formulation, labeling, packing of different types of

pharmaceutical dosage forms.

Students should be able to formulate and evaluate semisolid, cosmetic and sterile

products.

Detailed Syllabus

Sr. No.


Section-I

1 Semisolid dosage forms:

Definition, advantages and disadvantages, types, mechanisms of drug

penetration through skin, factors influencing penetration, semisolid

10

bases selection and ideal requirements of bases, formulation and

formulation ingredients, manufacturing procedure, evaluation, labelling,

packaging and storage requirements of following semisolids dosage

form:

Gels, ointments, suppositories, pessaries, poultice and plasters other I.P.

semi solid products.

2 Fundamentals of cosmetic products:

Fundamentals of cosmetic science, structure and functions of skin and

hair, brief introduction to cosmaceuticals.

02

3 Cosmetic preparations:

Definition, advantages and disadvantages, formulation, preparation,

labelling, packaging and storage requirements of following cosmetic

products.

Cosmetics for skin: Sunscreen, moisturizers, cold cream, vanishing

cream, cleansing cream, foundation cream, moisturising cream, rouge,

lather shaving products etc.

Cosmetics for hair: Shampoo, conditioners etc.

Dentifrice cosmetic: Tooth gels, tooth paste etc.

Manicure preparations: Nail polish, lipsticks, eye lashes, mascara, baby

care products, compact face powder etc.

10

Section-II

4 Pharmaceutical aerosols:

Definition, propellants, general formulation of aerosols, containers,

manufacturing (cold filling and pressure filling technique) and packaging

methods, Inhalaer, metered dose inhaler, pharmaceutical applications,

05

evaluation of aerosol.

5 Sterile dosage forms:

Definitions, advantages, disadvantages, Ideal requirements, aseptically

prepared and terminally sterilized products, formulation, Water for

injection: Preparation, Storage and quality control. containers and

closures, Design and requirements for production area- Aseptic

techniques, Clean Room classification, manufacturing process, methods

of filling including form fill and seal technology, methods of sealing,

sources of contamination and methods of prevention, evaluation of

sterile dosage forms, Labelling requirements, Parentral suspensions and

emulsion, Prefilled syringes, Total parentral nutrients, Freeze dried

products, and sterile I.P. Products.

15

6 Opthalmic preparations: Eye drops, Eye lotion, and other opthalmic

products.

03

Pharmaceutical Technology I (Practical)

1. Formulation and evaluation of cold cream.

2. Formulation and evaluation of vanishing cream.

3. Formulation and evaluation of foundation cream/cleansing cream.

4. Formulation and evaluation of simple ointment IP preparation..

5. Formulation and evaluation of non staining iodine ointment.

6. To find out displacement value of medicament/cocoa butter using suppositories mould.

7. Formulation and evaluation of suppositories.

8. Formulation and evaluation of eye drops.

9. Formulation and evaluation of eye lotion.

10. Formulation and evaluation of gel preparation.

11. Formulation and evaluation of lather shaving cream

12. Formulation and evaluation of lipstic preparation.

13. Formulation and evaluation of tooth paste.

14. Formulation and evaluation of calcium gluconate injection.

15. Formulation and evaluation of dextrose injection.

16. Formulation and evaluation of NaCl injection.

17. Formulation and evaluation of dextrose saline injection.

18. Perform pharmacopoeial test for given sample of glass vial / ampoule.

19. Other practicals covering syllabus aspects.






The course includes a laboratory, where students have an opportunity to build an

appreciation for the concepts being taught in lectures.


By the end of this course, the student should have a good understanding of basic process

which are used in different stage during preparation of pharmaceutical formulation.

Students should be able to know formulation, labeling, and packing of different types of

pharmaceutical products.

Text Books:

7. Dispensing for pharmaceutical students” by Copper and Gunn by S.J.Carter, 12th Edn.

CBS Publishers.

8. The Theory and Practice of Industrial Pharmacy by L Lachman, H Lieberman and J

Kanig.

9. Pharmaceutical Dosage Forms and Drug Delivery Systems by Ansel & others.

10. Handbook Of Cosmetics by Mithal B.M., Vallabh publication.

11. Cosmetics Formulation Manufactoring & Quality Control by Sharma , Vandana

Pub.Delhi.

Reference Books:

6. The Science & Practice of Pharmacy: A. G. Remington; Lippincott, Philadelphia.

7. Cosmetics by Poucher.

8. Pharmaceutical Dosage Forms: Tablets: Vol.1, Vol. 2 and Vol.3, Ed. by Lieberman, Leon

Lachman and Joseph B. Schwartz, Marcel Dekker Inc., New York.

9. Pharmaceutical Dosage Forms: Parenteral Medication: Vol.1, Vol. 2 and Vol.3, Ed. by

Lieberman, Leon Lachman and Joseph B. Schwartz, Marcel Dekker Inc.,New York.

10. Modern Pharmaceutics by Gilbert S. Banker and Christopher T. Rhodes, Marcel

Dekker, Inc., New York.

11. Pharmaceutics: The Science of Dosage Form Design by Michael E. Aulton.


Soft copies of pharmaceutical technology books are available on

http://www.pharmatext.org, www.pharmacyebooks.com, and in

www.pharmamirror.com.

Latest information regarding pharmaceutical technology are available on

http://www.pharmainfo.net

Study materials of pharmaceutical technology are available on mypharmaguide.com,

pharmatutor.com, authorstream.com, slideworld.com and in scribd.com.

Review articles published in international journal covering syllabus aspect.

Documents

Section-I - rku.ac.inrku.ac.in/syllabus/syllabus/SOP-Bpharm-Sem-5-Bpharm-2018-2019-SOP-RKU.p…3 Immunology and Immunological Preparation: Immunity, primary and secondary defense mechanism,